N/A
Completed N=30
Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome
Amplified Musculoskeletal Pain Syndrome · Reflex Sympathetic Dystrophy · Complex Regional Pain Syndromes
Source: ClinicalTrials.gov NCT03762213 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: The Mean Change in Pain Intensity Reported on Visual Analog Scale (VAS) — -14.9; -9.6 units on a scale
Summary
A pilot randomized controlled trial to assess feasibility, acceptability and generate outcome domains for a future RCT testing the efficacy of immersive virtual reality on pain intensity in pediatric amplified musculoskeletal pain syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Change in Pain Intensity Reported on Visual Analog Scale (VAS) |
-14.9; -9.6 | — |
| SECONDARY Mean Change in Pain Catastrophizing Reported on Pain Catastrophizing Scale - Child (PCS-C) |
-2.0; -2.9 | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of AMPS, including CRPS, or localized or diffuse amplified pain syndrome as determined by the primary pediatric rheumatologist and coded in EMR.
- Informed consent for caregivers and child assent for participants.
Exclusion Criteria
- An underlying organic cause can explain the pain including inflammatory, infectious, traumatic or malignant etiologies as determined by the primary pediatric rheumatologist.
- Participant or caregiver report of any history of motion sickness, underlying epilepsy, severe headaches in the participant or other conditions where the use of visual exposures to stimuli is contraindicated.
- Inability to report a pain score and/or incapacity to give assent due to intellectual deficit.
- Blindness.
- Non-English-speaking subjects will be excluded due to the unavailability of the content of the VR application used in this study in languages other than English.
- Any other condition that the investigators think can compromise the integrity of the study or subject safety.
Data sourced from ClinicalTrials.gov (NCT03762213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.